Back to resultsTreatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
Primary Purpose
Autoimmune Pancreatitis, IgG4-related Sclerosing Cholangitis, Obstructive Jaundice
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
corticosteroids
biliary stent
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- adults greater than 18 years-old;
- autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
- obstructive jaundice
Exclusion Criteria:
- malignancies; active infections;
- pregnancy or breast feeding;
- standard contraindications to ERCP;
- unwillingness or inability to consent for the study
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Steroids group
Stent group
Arm Description
The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.
The patients will be treated with oral corticosteroids and biliary stent.
Outcomes
Primary Outcome Measures
Clinical remission rate of obstructive jaundice
Secondary Outcome Measures
Full Information
NCT ID
NCT02797665
First Posted
June 6, 2016
Last Updated
July 12, 2020
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02797665
Brief Title
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
5. Study Description
Brief Summary
This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half of participants will receive corticosteroids alone, while the other half will receive corticosteroids with biliary stent at the beginning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Pancreatitis, IgG4-related Sclerosing Cholangitis, Obstructive Jaundice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Steroids group
Arm Type
Active Comparator
Arm Description
The patients will be treated with oral corticosteroids (prednisone 0.6mg/kg/d) alone.
Arm Title
Stent group
Arm Type
Active Comparator
Arm Description
The patients will be treated with oral corticosteroids and biliary stent.
Intervention Type
Drug
Intervention Name(s)
corticosteroids
Intervention Description
prednisone 0.6mg/kg/d
Intervention Type
Procedure
Intervention Name(s)
biliary stent
Intervention Description
placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)
Primary Outcome Measure Information:
Title
Clinical remission rate of obstructive jaundice
Time Frame
Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults greater than 18 years-old;
autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
obstructive jaundice
Exclusion Criteria:
malignancies; active infections;
pregnancy or breast feeding;
standard contraindications to ERCP;
unwillingness or inability to consent for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aiming Yang, M.D.
Phone
+86-10-69151593
Email
yangaiming@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiming Yang, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiming Yang, M.D.
Phone
+86-10-69151593
Email
yangaiming@medmail.com.cn
12. IPD Sharing Statement
Learn more about this trial
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids
We'll reach out to this number within 24 hrs